WISP Wisp Mask, Fabric Frame, with magnetic clips, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00606959006829), received between Apr 1, 2019 and Jan 3, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT AN END USER EXPERIENCED NAUSEA, THROWING UP, SEVERE ATRIAL FIBRILLATION AND LOW HEART RATE WHILE USING THE WISP MASK WITH MAGNETS. THE END USER ALLEGES HE WAS HOSPITALIZED IN SEPTEMBER 2021 FOR 3 TO 4 DAYS TO STABILIZE HIS HEART AND HAVE HIS PACEMAKER CHECKED. MULTIPLE ATTEMPTS TO OBTAIN MORE INFORMATION WERE UNSUCCESSFUL. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

  Patient problems: Arrhythmia; Atrial Fibrillation; Bradycardia; Nausea; Vomiting

  MAUDE report 16086464 ↗
• MalfunctionNov 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT AN END USER ALLEGEDLY RECEIVED THE WISP MASK WITH MAGNETIC CONNECTIONS AND WAS CONCERNED BECAUSE SHE HAS A PACEMAKER/DEFIBRILLATOR AND WAS WORRIED THE MAGNETIC CLIPS WOULD AFFECT HER HEART. THE USER WAS INSTRUCTED TO KEEP THE MASK 6-8 INCHES FROM HER HEART AND TO ALSO SPEAK WITH HER DOCTOR. THE USER IS CONCERNED WHEN TURNING IN HER SLEEP SHE MIGHT CAUSE HERSELF HARM. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE WISP INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING WARNINGS: THE HEADGEAR CLIPS CONTAIN MAGNETS. CONTACT YOUR HEALTHCARE PROFESSIONAL BEFORE YOU USE THIS MASK. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 2 IN. (50 MM) AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRILLATORS, AND COCHLEAR IMPLANTS. DO NOT USE IN OR NEAR MAGNETIC RESONANCE IMAGING (MRI) EQUIPMENT. KEEP UNASSEMBLED MAGNETIC HEADGEAR CLIPS OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL SWALLOWING, SEEK MEDICAL ASSISTANCE IMMEDIATELY. THE MANUFACTURER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761076 ↗
• InjuryOct 17, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT AN END USER ALLEGED THAT SHE EXPERIENCED LIGHTHEADEDNESS, DIZZINESS, AN IRREGULAR HEARTBEAT, AND CHANGES TO HEART RATE AT NIGHT AFTER WEARING THE WISP MASK WITH MAGNETIC CONNECTIONS. THE USER HAD PACEMAKER PLACED IN (B)(6) 2022 AND HAS A MONITOR IN HER ROOM THAT SHE USES WHILE SLEEPING. THE MONITOR HAS ALLEGEDLY ALERTED HER TO DRAMATIC CHANGES IN HEART RATE AT NIGHT. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE MANUFACTURER GAVE INFORMATION ON THE PLASTIC CLIPS FOR THE WISP MASK AND INSTRUCTED THE USER TO STOP USING THE MASK UNTIL SHE CONTACTS HER CARDIOLOGIST AND DME FOR PLASTIC CLIPS. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE WISP INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING WARNINGS: THE HEADGEAR CLIPS CONTAIN MAGNETS. CONTACT YOUR HEALTHCARE PROFESSIONAL BEFORE YOU USE THIS MASK. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 2 IN. (50 MM) AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRILLATORS AND COCHLEAR IMPLANTS. DO NOT USE IN OR NEAR MAGNETIC

  Patient problems: Arrhythmia; Dizziness

  MAUDE report 15615362 ↗
• InjuryMar 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION FROM A USER THAT WHILE USING THE WISP MASK WITH MAGNETIC CLIPS WITH HIS CPAP DEVICE, HE REPORTED THAT HE EXPERIENCED HEADACHES RIGHT AFTER HE STARTED USING IT. THE USER REPORTS HE WORE THE MASK WITH MAGNETS A FEW YEARS BEFORE HE REALIZED THAT THE HEADACHES AND COGNITIVE ISSUES FROM THE HEADACHES WERE FROM THE MAGNETS IN HIS MASK . THE USER REPORTED SEVERAL CAT SCANS AND A VISIT TO THE HOSPITAL FOR THE SHUNT IN HIS HEAD TO BE ADJUSTED. THE USER REPORTED HE STOPPED USING HIS MASK WHEN HIS CPAP MACHINE BROKE (B)(6) 2019. THE USER NO LONGER HAS THE WISP MASK WITH THE MAGNETIC CLIPS. NO PRODUCT WILL BE RETURNING FOR INVESTIGATION. THE WISP INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING WARNINGS: THE HEADGEAR CLIPS CONTAIN MAGNETS. CONTACT YOUR HEALTHCARE PROFESSIONAL BEFORE YOU USE THIS MASK. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 2 IN. (50 MM) AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRILLATORS AND COCHLEAR IMPLANTS. DO NOT USE IN OR NEAR MAGNETIC RESONANCE IMAGING (MRI) EQUIPMENT. KEEP UNASSEMBLED MAGNETIC

  Patient problems: Cognitive Changes; Headache

  MAUDE report 13666050 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT A USER AFTER WEARING A WISP MASK WITH MAGNETIC CONNECTIONS, THE USER REPORTEDLY HAD A SEIZURE. THE USER HAS A HISTORY OF SEIZURES AND HAS AN IMPLANTED SHUNT AND VNS FOR HIS SEIZURES. THE FOLLOWING DAY IT WAS ALSO REPORTED THE USER SUFFERED 7 ADDITIONAL SEIZURES. THE MOTHER OF THE USER REPORTED SHE IS NOT SURE IF THE SEIZURES WERE RELATED TO THE MAGNETS IN THE MASK OR NOT. THERE WAS NO REPORT OF MEDICAL INTERVENTION. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE USER'S MOTHER FOR THE RETURN OF THE MASK FOR INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE WISP INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING WARNINGS: THE HEADGEAR CLIPS CONTAIN MAGNETS. CONTACT YOUR HEALTHCARE PROFESSIONAL BEFORE YOU USE THIS MASK. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 2 IN. (50 MM) AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRILLATORS AND COCHLEAR IMPLANTS. DO NOT USE IN OR NEAR MAGNETIC RESONANCE IMAGING (MRI) EQUIPMENT. KEEP UNASSEMBLED MAGNETIC HEADGEAR CLIPS OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL S

  Patient problems: Convulsion/Seizure

  MAUDE report 13666049 ↗
• InjuryApr 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION BY AN END USER THAT SHE REQUIRED SURGERY (LABIAL FRENOTOMY) AND A BONE GRAFT DUE TO HER FRONT TEETH SHIFTING WHILE USING THE WISP NASAL MASK. THE USER STATED THE EVENT OCCURRED "SOMETIME BETWEEN 2017 AND 2018". THE LENGTH OF TIME THE MASK WAS IN USE IS UNKNOWN; HOWEVER, THE USER STATED IT TOOK "A COUPLE OF YEARS" OF USE BEFORE SHE REQUIRED SURGERY. NO LOT NUMBER OR PART NUMBER HAS BEEN PROVIDED. PART NUMBER 1094051 IS BEING ASSIGNED FOR THIS REPORT FOR TRENDING PURPOSES ONLY, AND MAY CHANGE IF ADDITIONAL INFORMATION IS PROVIDED. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Injury; Tissue Damage

  MAUDE report 8470907 ↗